Biotech Values

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"The FDA's letter requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information that we already planned on filing with our 120 day safety update in April, as well as additional statistical analysis clarification," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "We believe that we will be able to provide the requested information in an updated application and we expect to resubmit the NDA by the end of the third quarter of this year.

Both safety data and stat analysis in RTF are very unusual. By the end of Sept for target resubmission, it seems they think it takes quite a long time to put these together.